U.S. patent application number 10/937134 was filed with the patent office on 2005-02-03 for guidewire system.
Invention is credited to Shiber, Samuel.
Application Number | 20050027309 10/937134 |
Document ID | / |
Family ID | 34705064 |
Filed Date | 2005-02-03 |
United States Patent
Application |
20050027309 |
Kind Code |
A1 |
Shiber, Samuel |
February 3, 2005 |
Guidewire system
Abstract
A flexible guidewire system for crossing an obstruction located
in a patient's vessel comprising a flexible tubular casing slidable
and rotatable over a pilot wire, the casing having an internal
tubular wire-shield, at least a distal portion of the casing being
a helical wire that is gated at its distal end, and a coupling
means connected to the casing for rotating and linearly moving the
casing and shield over the pilot wire.
Inventors: |
Shiber, Samuel; (Manchester,
NH) |
Correspondence
Address: |
SAMUEL SHIBER
365 KEARNEY CR
MANCHESTER
NH
03104
US
|
Family ID: |
34705064 |
Appl. No.: |
10/937134 |
Filed: |
September 9, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10937134 |
Sep 9, 2004 |
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10620740 |
Jul 16, 2003 |
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10937134 |
Sep 9, 2004 |
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10463189 |
Jun 17, 2003 |
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Current U.S.
Class: |
606/159 |
Current CPC
Class: |
A61M 25/09 20130101;
A61B 17/320758 20130101; A61B 2017/22044 20130101; A61M 25/01
20130101; A61B 2017/22047 20130101; A61B 17/3207 20130101 |
Class at
Publication: |
606/159 |
International
Class: |
A61B 017/22 |
Claims
1. A flexible guidewire system, for crossing an obstruction located
in a patient's vessel, comprising: a flexible pilot wire; a
flexible tubular casing having a tubular shield disposed in said
casing, said casing and said shield being slidable and rotatable
over said pilot wire, at least a distal portion of said casing
being a helical wire that is gated at its distal end; and a
coupling means connected to said casing for rotating and linearly
moving said casing and said shield over said pilot wire.
2. As in claim 1 wherein a proximal end of said shield is affixed
to said casing.
3. As in claim 2 wherein said proximal end of said shield is
hydraulically connected to an external port.
4. As in claim 1, wherein said distal end of said helical wire is
gated by closely wound coils of said helical wire.
5. As in claim 4, wherein a distal end of said shield is slidably
disposed in said helical wire.
6. As in claim 1, wherein said helical wire comprises a distal end
that is gated by a tube section.
7. As in claim 6, wherein said distal end of said shield is
connected to said tube section.
8. As in claim 1, wherein said casing has a midsection that
comprises a helical wire with distantly spaced coils.
9. As in claim 8, wherein said distal portion of said casing and
said midsection of said casing are wound of a continuous wire.
10. As in claim 1, wherein said distal portion of said casing is
curved.
11. As in claim 1, wherein said flexible pilot wire is a standard
guidewire.
12. As in claim 1, wherein said flexible guidewire system is
disposed in a sleeve with a biasing means to deflect said casing in
the vessel.
13. As in claim 12, wherein said sleeve comprises a pre-curved
distal end section.
14. As in claim 12, wherein said sleeve comprises a selectively
inflatable chamber formed at said distal end of said sleeve.
15. A process for crossing an obstruction in a patient's vessel
comprising: inserting through the vessel, to an obstruction, a
flexible pilot wire; advancing through the vessel over said pilot
wire a flexible tubular casing containing an internal tubular pilot
wire shield, at least a distal end of said casing being a helical
wire that is gated at its distal end, and a proximal coupling means
connected to said casing for rotating and linearly moving said
casing and said shield over said pilot wire; and threading said
casing through the obstruction.
16. As in claim 15 wherein radio-opaque fluid is injected into said
vessel through said distal end of said shield.
17. As in claim 15, wherein a portion of said pilot wire is
inserted distally to said casing, into said vessel, thereby
providing a lever arm to angularly align said casing with the
vessel.
18. A process for crossing an obstruction in a patient's vessel
comprising: inserting through the vessel, to an obstruction, a
flexible pilot wire; advancing through the vessel over said pilot
wire a flexible tubular casing containing an internal tubular
shield, at least a distal end of said casing being a helical wire
that is gated at its distal end, and a proximal coupling means
connected to said casing for rotating and linearly moving said
casing and said shield over said pilot wire; advancing and rotating
said casing, through said coupling means, beyond a distal tip of
said pilot wire and threading it across the obstruction; advancing
said pilot wire across the obstruction; and withdrawing said casing
while leaving said pilot wire in the vessel.
19. As in claim 18 wherein fluid is injected through said distal
end of said shield.
20. As in claim 18, wherein a portion of said pilot wire is
inserted distally to said casing, into said vessel, thereby
providing a lever arm to angularly align said casing with said
vessel.
21. A process for crossing an obstruction in a patient's vessel
comprising: inserting into and advancing through the vessel a
flexible tubular casing containing an internal tubular shield, at
least a distal end of said casing being a helical wire that is
gated at its distal end, and a proximal coupling means connected to
said casing for rotating and linearly moving said casing and said
shield; advancing and rotating said casing, through said coupling
means, thereby threading it across the obstruction; inserting a
pilot wire through said casing into the vessel and across the
obstruction; and withdrawing said casing while leaving said pilot
wire in the vessel.
22. As in claim 21, comprising additionally a step of entering into
the vessel a sleeve with a biasing means at its distal end, whereas
said casing is entered into the vessel through said sleeve and said
biasing means is used to deflect the position of said casing in
said the vessel.
23. As in claim 22, wherein said sleeve comprising a selectively
inflatable chamber formed at said distal end of said sleeve.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part (CIP) of
co-pending application Ser. No. 10/620740, filed on Jul. 16, 2003
(CT23), and also a CIP of another co-pending application Ser. No.
10/463189, filed on Jun. 17, 2003 (CT22).
[0002] All of the above are being incorporated herein by
reference.
BACKGROUND AND OBJECTIVES OF THE INVENTION
[0003] With age a large percentage of the population develops
atherosclerotic and thrombotic obstructions resulting in partial or
total occlusions of blood vessels in various parts of the human
anatomy. Such obstructions are often treated with angioplasty or
atherectomy catheters. A common preparatory step to such procedures
is inserting a guidewire through the obstruction.
[0004] An objective of the present invention is to provide a simple
and reliable flexible guidewire system capable of crossing tortuous
vasculature and obstructions, particularly tight and total
obstructions.
[0005] The above and other objectives of the invention will become
apparent from the following discussion and the accompanying
drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0006] FIG. 1 schematically shows a side view of a flexible
guidewire system for crossing an obstruction in a vessel comprising
a pilot wire over which a tubular casing with an internal tubular
shield are slidable and rotatable through a coupling, being
inserted at the patient's groin area, through his arterial system
into his obstructed coronary artery;
[0007] FIGS. 2 and 3 show enlarged proximal and distal portions,
respectively, of the guidewire system shown in FIG. 1;
[0008] FIG. 4 shows additional details of the guidewire system;
[0009] FIG. 5 shows a guidewire system where the distal end section
of the tubular casing is pre-curved;
[0010] FIGS. 6, 7 and 8 show alternative flattened cross sections
of wires that can be used to wind the casing;
[0011] FIG. 9 shows a modified distal end of a casing wherein the
distal end of the shield is connected to a tube section through
matching conical surfaces;
[0012] FIG. 10 shows an end view of the casing shown in FIG. 9;
[0013] FIG. 11 shows a modified distal end of a casing which is
gated by a weld connecting the two most distal coils;
[0014] FIG. 12 shows an end view of the casing shown in FIG.
11;
[0015] FIG. 13 shows a partially cross sectioned view of a
guidewire system in a flexible sleeve, with an inflatable chamber
located at the distal end of the sleeve;
[0016] FIG. 14 shows a cross-sectional view along line 14-14 marked
on FIG. 13;
[0017] FIG. 15 shows a partially cross sectioned view of a
guidewire system in a flexible sleeve, with a selectively
actuatable tongue at a distal end of said sleeve; and,
[0018] FIG. 16 shows a cross-sectional view along line 16-16 marked
on FIG. 15.
DETAILED DESCRIPTION OF THE DRAWINGS
[0019] FIGS. 1, 2 and 3 show a flexible guidewire system 10 made of
elongated components that are rotatable and slidable one relative
to the other (the components' ends that go further into the vessel
are referred to as "distal" and their other ends are referred to as
"proximal"). The system is shown crossing an obstruction 12 located
in a patient's coronary vessel 13 serving the heart 11 (the
patient's anatomy and the system are illustrated schematically and
are not drawn to scale).
[0020] The system 10 comprises a flexible pilot wire 9, a flexible
tubular casing 8 (note also FIG. 4) having an internal tubular
pilot wire shield 7 disposed in and affixed to the casing. The
casing and the shield are slidable and rotatable over the pilot
wire. The flexible pilot wire can be a standard guidewire
(guidewires are sold by numerous companies, e.g.: Boston
Scientific, Natick, Mass.; Cook, Bloomington, Ind.). At least a
distal portion 6 of the casing is a helical wire that is gated at
its distal end by a tube section 19 that is secured to the helical
wire by a weld 49' (note FIG. 3). A coupling means, in the form of
a tube 17 is connected to the casing by a weld 49 (note FIG. 4) for
rotating and linearly moving the casing and the shield over the
pilot wire.
[0021] The system 10 can be introduced into the patient's arterial
system 16 through a flexible sleeve 71 that isolates it from the
vessels' walls and directs the system to the obstruction site. An
external port 72 is connected to the flexible sleeve through an
annular chamber 73 that is attached to the proximal end of the
sleeve. The chamber is equipped with a seal 74 that seals around a
smooth outer surface of the tube 17. Optionally, the distal end
section of the sleeve can be pre-curved, as shown in FIG. 1 and
marked 71', to direct the distal end of the system into a specific
vessel and selectively bias it inside the vessel. The sleeve 71 can
be inserted into the vasculature directly or through a standard
introducer 20 having a port 72', a chamber 73' and a seal 74' that
seals on the outer surface of sleeve 71 (standard introducers are
sold by numerous companies, e.g.: Boston Scientific, Natick, Mass.;
Cook, Bloomington, Ind.).
[0022] The shield 7 has an open distal end and a proximal end that
is connected to a rotating Y-connector 52, through its rotatable
portion 53, that is a one part of a luer fitting (such rotating
Y-connectors are sold by numerous companies, e.g.: EV3, Plymouth,
Minn.). A second mating part of the luer fitting 54 is affixed
(e.g., bonded) to both a proximal end of the tube 17 and to a
proximal end of the shield 7. Thus, upon tightening the two parts
of the luer fitting, the proximal end of the casing is coupled to
the rotatable portion of the Y-connector through the tube 17 and
the proximal end of the shield is also coupled to the rotatable
portion of the Y-connector. The tightened luer fitting also
hydraulically connects the shield to an external port 51 and a seal
56, incorporated in the rotary Y-connector, prevents leakage
through the rotary connection.
[0023] At its proximal end the Y-connector is equipped with a
compression-seal 57, the internal diameter of which decreases in
response to tightening of a threaded cap 58 which reduces the
length of the seal causing it to elastically deform and close the
gap around the pilot wire 9, or in the absence of a pilot wire, to
shut the proximal end of the Y-connector.
[0024] As illustrated in FIGS. 1 and 2, the system can be held by a
single hand with the thumb and index finger imparting rotation to
the luer fitting and thereby to the casing 8. An optional syringe
59, preferably with a small diameter piston suitable for generating
higher pressures, is connected to the port 51 and can be used to
deliver fluid (e.g., saline solution, radio-opaque fluid, drugs)
through the distal end of the shield.
[0025] FIG. 3. shows the distal end of the system, wherein the
distal portion of the casing is gated by the tube section 19 that
is affixed to the casing by the weld 49'. A gap between the distal
end of the shield 7 and the tube section 19 prevents interference
between them when the casing is longitudinally compressed. The
distal end of the wire 4 is ground down to form a smooth inclined
plane to ease its penetration and minimize the likelihood of trauma
to the vasculature 16 or to the vessel 13.
[0026] FIG. 4 shows further details of the casing 8 that is
preferably made of a distal section 6 in the form of closely wound
coils and a midsection 5 in the form of distantly spaced coils and
both are wound from a continuous wire 4 for enhanced integrity. The
closely wound coils provide enhanced flexibility whereas the
distantly spaced coils provide enhanced torsional and longitudinal
rigidity thereby reducing the elastic angular and linear
deformation between the distal and proximal ends of the casing
under torque and linear loading, respectively. As shown in FIGS. 3
and 4, the wire 4 has a round cross section, however,
alternatively, the casing can be wound from a wire with a flattened
cross-section, examples of which are shown in FIGS. 6, 7 and 8. The
distal portion 6 can be relatively straight, as shown in FIG. 4.
Alternatively, it can be pre-curved, as shown in FIG. 5, so that as
the casing is rotated to start penetrating the obstruction 12, the
distal tip moves along a circular path 40, increasing the
probability that the distal tip would locate a soft point in a
proximal end of the obstruction to start threading itself into.
Once inside the obstruction, the pre-curvature can be altered by
the surrounding obstruction to adapt to the trajectory of the
distal end as it penetrates through the obstruction material.
[0027] The tube 17 is welded to the proximal end of the casing, and
essentially serves as an extension of its proximal end with a
smooth outside surface that provides a surface suitable for the
seal 74 to seal against while the tube 17 is rotated and linearly
moved through it. Alternatively, the system can be inserted
directly through the introducer 20, in which case the seal 74'
provides the sealing around the tube 17. The casing can be driven
(i.e., advanced and rotated), through the tube 17, by the
physician's hand. Alternatively, a motor 28 (shown in FIG. 1 in
intermittent line) can provide the rotation through its hollow
output shaft 29 that is frictionally engaged with the tube 17,
while the linear motion can be still provided by the a physician
hand that holds the motor.
[0028] FIGS. 9 and 10 show a side view and an end view,
respectively, of a modified distal end of a system wherein the
distal end of the casing is gated by a tube section 19' that is
connected, through matching conical surfaces, to the shield 7'. As
shown in FIG. 10, the distal end of the wire 4 is ground down to
form a smooth inclined plane to ease its penetration and minimize
the likelihood of trauma to the vasculature 16 or to the vessel
13.
[0029] FIGS. 11 and 12 show a side view and an end view,
respectively, of a modified distal end of the system wherein the
distal end of the flexible casing 6' is gated by two distal coils
31 that are closely wound so that the spacing between them is
smaller than the diameter of the pilot wire. Preferably, the coils
are welded one to the other by a weld 48. The weld 48 also assures
that fibrous material that may be encountered in the artery does
not work its way in-between the coils when the casing is rotated
and threaded through the obstruction. The distal end of the shield
is slidably disposed inside the distal end of the casing so that it
does not protrude out of it when the casing slightly compresses and
shortens.
[0030] FIGS. 13 and 14 show cross-sectioned side and end views,
respectively, of a biasing means in the form of an asymmetrical
inflatable chamber 81 formed at the distal end of a flexible
deflecting sleeve 82 which, when inflated through a channel 83
formed in the sleeve's wall, bears against the vessel's wall,
eccentrically biasing the flexible sleeve in the vessel. When
deflated, the chamber conforms to the sleeve to minimize
interference with its insertion into the vessel. Alternatively, the
chamber can be shaped as an asymmetrical toroidal inflatable
chamber 81' as shown in FIG. 14 by interrupted lines. This chamber,
when inflated, establishes peripheral contact with the vessel's
wall and thereby blocks blood flow between the sleeve and the
vessel's wall, as well as eccentrically biases the sleeve (it can
be understood that a symmetrical toroidal chamber can be provided
for the purpose of blocking the flow around the sleeve while
centering the biasing sleeve).
[0031] FIGS. 15 and 16 show cross-sectioned side and end views,
respectively, of flexible sleeve 76 that has a tongue 77 which can
be used to bias the sleeve in the vessel. The tongue can be
energized against the vessel wall by pulling a flexible rope 79 and
thereby moving the tongue from its relaxed position to the position
shown in FIGS. 15 and 16.
Operation
[0032] The previously described system, shown in FIGS. 1, 2 and 3,
can be operated as following. The distal portion of the flexible
pilot wire is inserted into a curved vessel, and assumes the
vessel's geometry. Then the casing is inserted through the
vasculature over the flexible pilot wire. The casing can be rotated
to assist in its advancement over the pilot wire through curves of
the vasculature while the flexible pilot wire guides the advancing
casing. The rotation of the casing substantially reduces the
longitudinal friction between the casing and the stationary pilot
wire as well as longitudinal friction between the casing and its
surroundings, i.e., the sleeve (assuming a sleeve is used) and the
vessel or vessels through which the casing is advanced towards the
obstruction. Further, if the casing in the form of a helical wire
is turned in the direction that the coils are wound, the rotation
generates a force that pulls and propels the casing forward through
the vessels. Such pulling force generated at the distal end is
significant because in order to deliver to the distal end the same
amount of force through a tortuous path (as the path through the
coronary vasculature commonly is), a larger push force would be
required to be applied to the proximal end of the casing which may
exceed the casing's columnar strength resulting in the casing
buckling.
[0033] Once the casing is brought to the obstruction, the process
of crossing an obstruction with a system according to the present
invention can be done as follows:
[0034] Advancing the flexible pilot wire into the obstruction,
preferably as far as it would go.
[0035] Inserting the casing to the obstruction and rotating it in
the direction so that the helical wire propels and threads itself
through the obstruction. In the process, the end of the helical
wire may be advanced past the distal tip of the pilot wire and then
the tip of the pilot wire may be advanced past the distal tip of
the casing in a leapfrog-like manner. Once the pilot wire is
advanced across the obstruction, the casing may be withdrawn,
optionally by rotating it in the opposite direction to unthread it
and to minimize longitudinal friction both with the pilot wire and
with the surrounding casing, leaving the pilot wire in place for
subsequent procedures such as angioplasty or atherectomy.
[0036] It is also possible to continue and rotate the casing, after
it has been threaded across the obstruction, to increase the
helical wire's proximal conveyance action, especially when working
in an obstruction with a slurry-like consistency such as fresh
blood clots.
[0037] The sequence of inserting the system's components into the
vessel may be varied. Steps may be combined to streamline the
procedure or added to improve it and to customize the procedure to
the individual characteristics of an obstruction and its location
and to the working preferences of the medical staff. For example,
the system may be introduced percutaneously through a sleeve and/or
an introducer or it may be introduced intra-operatively, i.e., by
accessing vessel directly while it is exposed surgically.
Additionally, a standard guiding catheter, either straight or
curved, may be inserted into the vessel and used as a sleeve or
biasing means to assist in positioning the system's components in
the obstruction site. Further, the pilot wire and the casing can be
pre-nested before they are inserted into the vessel.
[0038] Further, a system according to the present invention can
have different diameters and lengths depending on the size and site
of the vessel that it is intended for and on whether the system is
to be used percutaneously or intra-operatively. For example, a
system that is intended to be introduced percutaneously at the
groin area for crossing an obstruction in a coronary vessel
preferably utilizes as a pilot wire a standard guidewire with a
0.014" ("denotes inches) diameter and a length of 120" with a
casing having an internal diameter of 0.020", an outside diameter
of 0.045" and a length of 50". The distal portion of the casing can
be 10" long, the midsection 30" long and the tube 17 can be 10"
long. If the system utilizes a larger diameter pilot wire, such as
an 0.035" guidewire, the casing diameters can be increased
accordingly. If the system is intended for use in peripheral
(non-coronary) blood vessels or where direct access to the vessel
is gained surgically (intraoperatively), the system can be
shorter.
[0039] The above mentioned and other modifications and
substitutions can be made in the system and in its operation within
the spirit of the invention and the scope of the following
claims.
* * * * *